Proxalutamide for COVID-19: real-time analysis of all 8 studies

Kintor Pharma Provides Update on One of its Three Multi-Regional Phase 3 Trials of Proxalutamide for COVID-19

Kintor, News Releease (News)

News release reporting on interim analysis of NCT04870606, showing that statistical criteria were not met, there was a very low event rate, and that Kintor plans to amend the protocol and continue to enroll higher risk patients.

Kintor et al., 12/27/2021, preprint, 1 author.

Final Results of a Randomized, Placebo-Controlled, Two-Arm, Parallel Clinical Trial of Proxalutamide for Hospitalized COVID-19 Patients: A Multiregional, Joint Analysis of the Proxa-Rescue AndroCoV Trial

Cadegiani et al., Cureus, doi:10.7759/cureus.20691 (Peer Reviewed)

RCT 778 hospitalized patients in Brazil, 423 treated with proxalutamide, showing significantly lower mortality and improved recovery with treatment. NCT04728802 and NCT05126628. Authors note that cases in this trial were predominantly the P.1 Gamma variant, for which proxalutamide may be more effective compared to other variants.

risk of death, 78.0% lower, RR 0.22, p < 0.001, treatment 45 of 423 (10.6%), control 171 of 355 (48.2%), NNT 2.7, adjusted, 28 days, Cox proportional hazards.

risk of death, 79.0% lower, RR 0.21, p < 0.001, treatment 34 of 423 (8.0%), control 138 of 355 (38.9%), NNT 3.2, adjusted, 14 days, Cox proportional hazards.

recovery rate, RR 0.55, p < 0.001, treatment 423, control 355, adjusted, 28 days, Cox proportional hazards.

recovery rate, RR 0.45, p < 0.001, treatment 423, control 355, adjusted, 14 days, Cox proportional hazards.

hospitalization time, 33.3% lower, relative time 0.67, p < 0.001, treatment 423, control 355.

Cadegiani et al., 12/25/2021, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 15 authors.

开拓药业普克鲁胺治疗新冠预计本月发布临床数据

Kintor, News Comments (News)

News report noting that real-world results for proxalutamide in Paraguay show signfiicantly lower mortality and are consistent with the results of previous studies in Brazil.

Kintor et al., 12/17/2021, preprint, 1 author.

Proxalutamide Improves Inflammatory, Immunologic, and Thrombogenic Markers in Mild-to-Moderate COVID-19 Males and Females: an Exploratory Analysis of a Randomized, Double-Blinded, Placebo-Controlled Trial Early Antiandrogen Therapy (EAT) with Proxalutamide (The EAT-Proxa Biochemical AndroCoV-Trial)

Cadegiani et al., medRxiv, doi:10.1101/2021.07.24.21261047 (Preprint)

Analysis of data from two proxalutamide early treatment RCTs with 445 patients showing substantial improvements in immunologic, inflammatory, thrombotic, and oxygen markers, which may support the observed reduction in hospitalization.

Cadegiani et al., 7/25/2021, preprint, 4 authors.

Kintor Pharmaceutical Receives Emergency Use Authorization for Proxalutamide for the Treatment of COVID-19 in Paraguay

Kintor Pharmaceutical News Release (News)

News release announcing that proxalutamide has been granted an emergency use authorization for COVID-19 in Paraguay.

Kintor et al., 7/16/2021, preprint, 1 author.

Proxalutamide (GT0918) Reduces the Rate of Hospitalization in mild-to-moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Two-Arm Parallel Trial

Cadegiani et al., medRxiv, doi:10.1101/2021.07.06.21260086 (Preprint)

RCT 177 women in Brazil, 75 treated with proxalutamide, showing significantly lower hospitalization with treatment.

risk of death, 63.4% lower, RR 0.37, p = 1.00, treatment 0 of 75 (0.0%), control 1 of 102 (1.0%), NNT 102, relative risk is not 0 because of continuity correction due to zero events.

risk of mechanical ventilation, 89.7% lower, RR 0.10, p = 0.07, treatment 0 of 75 (0.0%), control 5 of 102 (4.9%), NNT 20, relative risk is not 0 because of continuity correction due to zero events.

risk of hospitalization, 85.7% lower, RR 0.14, p < 0.001, treatment 2 of 75 (2.7%), control 19 of 102 (18.6%), NNT 6.3.

Cadegiani et al., 7/10/2021, Double Blind Randomized Controlled Trial, Brazil, South America, preprint, 7 authors.

Proxalutamide (GT0918) Reduction of Mortality Rate in Hospitalized COVID-19 Patients Depends on Treatment Duration - an Exploratory Analysis of the Proxa-Rescue AndroCoV Trial

Zimerman et al., medRxiv, doi:10.1101/2021.06.28.21259661 (Preprint)

Analysis of treatment duration in the Proxa-Rescue AndroCoV trial showing significantly higher mortality among patients that interrupted treatment with proxalutamide. NCT04728802.

Zimerman et al., 7/2/2021, preprint, 17 authors.

Proxalutamide (GT0918) Improves Lung Injury in Hospitalized COVID-19 Patients -an Analysis of the Radiological Findings of the Proxa-Rescue AndroCoV Trial

Medeiros et al., ResearchGate (Preprint)

Analysis of radiological findings from the Proxa-Rescue AndroCoV trial showing that proxalutamide significantly improves lung opacities compared to placebo. NCT04728802.

Medeiros et al., 7/1/2021, preprint, 23 authors.

Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial

Cadegiani et al., Cureus, doi:10.7759/cureus.13492 (Peer Reviewed)

RCT 234 mild-moderate COVID-19 patients with 171 treated with proxalutamide, showing significantly faster viral clearance and recovery. Third party analysis suggests potential randomization failure: [1].

[1] steamtraen.blogspot.com/2021/10/applying-john-carlisles-table-1.html

risk of no virological cure, 92.1% lower, RR 0.08, p < 0.001, treatment 7 of 171 (4.1%), control 34 of 66 (51.5%), NNT 2.1, day 7, not including loss of taste or smell.

risk of no recovery, 76.8% lower, RR 0.23, p < 0.001, treatment 30 of 171 (17.5%), control 50 of 66 (75.8%), NNT 1.7, day 7, including loss of taste or smell.

recovery time, 85.0% lower, relative time 0.15, treatment 171, control 66, day 7, not including loss of taste or smell.

recovery time, 80.7% lower, relative time 0.19, treatment 171, control 66, day 7, including loss of taste or smell.

Excluded in meta analysis: potential randomization failure based on a third-party analysis.

Cadegiani et al., 2/22/2021, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 8 authors.

Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial

McCoy et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (preprint 12/30/2020) (Peer Reviewed)

RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. NCT04446429. Expression of concern: [1].

[1] frontiersin.org/articles/10.3389/fmed.2021.831449/full

risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 134 (0.0%), control 2 of 134 (1.5%), NNT 67, relative risk is not 0 because of continuity correction due to zero events.

risk of mechanical ventilation, 97.1% lower, RR 0.03, p < 0.001, treatment 0 of 134 (0.0%), control 17 of 134 (12.7%), NNT 7.9, relative risk is not 0 because of continuity correction due to zero events.

risk of hospitalization, 91.0% lower, RR 0.09, p < 0.001, treatment 3 of 134 (2.2%), control 35 of 134 (26.1%), NNT 4.2.

McCoy et al., 12/30/2020, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 15 authors.

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